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NCT00424047 · ADVERSE EVENTS

Adverse events

A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma · Source last updated 2017-10-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
From first dose of study drug to 30 days after the last visit. Up to 25 Jun 2013 (90 Months).
Other-event reporting threshold
5%

Includes adverse events for those who received Lenalidomide after unblinding.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Lenalidomide Plus Dexamethasone

Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.

105 / 176175 / 176Not reported / Not reported
Placebo Plus Dexamethasone

Placebo PO daily on Days 1 to 28 of each 28 day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.

79 / 175173 / 175Not reported / Not reported

Group identifiers: EG000: Lenalidomide Plus Dexamethasone · EG001: Placebo Plus Dexamethasone

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      175
    term
    PNEUMONIA NOS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      175
    term
    RESPIRATORY TRACT INFECTION NOS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      175
    term
    SEPSIS NOS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      175
    term
    SEPTIC SHOCK
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
    term
    UPPER RESPIRATORY TRACT INFECTION NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
    term
    BRONCHOPNEUMONIA NOS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      175
    term
    CELLULITIS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
    term
    ARTHRITIS BACTERIAL
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
    term
    BRONCHITIS ACUTE NOS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
    term
    HERPES ZOSTER
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      175
    term
    HERPES ZOSTER OPHTHALMIC
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
    term
    LOBAR PNEUMONIA NOS

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      175
    term
    NEUTROPENIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      175
    term
    ANAEMIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      175
    term
    THROMBOCYTOPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      175
    term
    LEUKOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      175
    term
    LYMPHOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      175
    term
    VERTIGO
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      175
    term
    CUSHINGOID
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      175
    term
    VISION BLURRED
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      175
    term
    CONSTIPATION
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      175
    term
    DIARRHOEA NOS
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      175
    term
    NAUSEA
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      175
    term
    DYSPEPSIA
Complete source fields
description
Includes adverse events for those who received Lenalidomide after unblinding.
event Groups
  1. description
    Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.
    id
    EG000
    other Num Affected
    175
    other Num At Risk
    176
    serious Num Affected
    105
    serious Num At Risk
    176
    title
    Lenalidomide Plus Dexamethasone
  2. description
    Placebo PO daily on Days 1 to 28 of each 28 day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.
    id
    EG001
    other Num Affected
    173
    other Num At Risk
    175
    serious Num Affected
    79
    serious Num At Risk
    175
    title
    Placebo Plus Dexamethasone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      175
    term
    NEUTROPENIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      175
    term
    ANAEMIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      175
    term
    THROMBOCYTOPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      175
    term
    LEUKOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      175
    term
    LYMPHOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      175
    term
    VERTIGO
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      175
    term
    CUSHINGOID
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      175
    term
    VISION BLURRED
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      175
    term
    CONSTIPATION
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      175
    term
    DIARRHOEA NOS
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      175
    term
    NAUSEA
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      175
    term
    DYSPEPSIA
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      175
    term
    PNEUMONIA NOS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      175
    term
    RESPIRATORY TRACT INFECTION NOS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      175
    term
    SEPSIS NOS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      175
    term
    SEPTIC SHOCK
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
    term
    UPPER RESPIRATORY TRACT INFECTION NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
    term
    BRONCHOPNEUMONIA NOS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      175
    term
    CELLULITIS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
    term
    ARTHRITIS BACTERIAL
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
    term
    BRONCHITIS ACUTE NOS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
    term
    HERPES ZOSTER
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      175
    term
    HERPES ZOSTER OPHTHALMIC
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      176
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
    term
    LOBAR PNEUMONIA NOS
time Frame
From first dose of study drug to 30 days after the last visit. Up to 25 Jun 2013 (90 Months).

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